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510(k) Data Aggregation

    K Number
    K201606
    Device Name
    LacriJet®
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2020-12-18

    (186 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K911109,K113536,K883233
    Why did this record match?
    Reference Devices :

    K911109

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LACRIJET® from 30 to 50 mm are indicated in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older.

    LACRIJET® with small size (15/20 mm) are indicated in the repair of canalicular lacerations.

    Device Description

    LacriJet® is a monocanalicular intubation device, with self-retaining punctal fixation for the treatment of monocanalicular lacerations and stenoses. The silicone stent acts as a conformer. The shape of the fixation head keeps the probe from migrating and from expulsing.

    AI/ML Overview

    The provided text is a 510(k) Pre-Market Notification from the FDA regarding the LacriJet® device. It details the device's indications for use, its comparison to predicate devices, and a summary of non-clinical tests.

    However, the document does not describe a study involving an AI/Machine Learning device that requires a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance. The LacriJet® is a physical medical device (a monocanalicular lacrimal stent), not a software or AI-based diagnostic/assessment tool.

    Therefore, it is not possible to extract the requested information regarding acceptance criteria met by a study, sample size, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these concepts are not applicable to the type of device and submission described in the FDA document.

    The document primarily focuses on establishing substantial equivalence based on:

    • Intended Use: Similar to predicate devices (MASTERKA, Eagle Vision Monocanalicular Stent, Mini-Monoka).
    • Technological Characteristics: Made of the same medical-grade silicone as a predicate, similar design for the stent and fixation head. The primary difference is in the delivery system, which the submission argues does not raise new safety or effectiveness concerns.
    • Non-Clinical Testing: Confirms the device meets established specifications related to biocompatibility, sterilization, package integrity, and shelf-life, demonstrating equivalence to the predicate device in these aspects.

    In summary, the provided text does not contain the information requested in your prompt as it pertains to a physical medical device clearance, not an AI/ML-driven device validation study.

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